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Decreasing the Impact of Diabetes in the Adult and Older Adults Decreasing the Impact of Diabetes in the Adult and Older Adults

Rural Health Population Utilizing Phone Calls as Part of the Rural Health Population Utilizing Phone Calls as Part of the

Chronic Care Management Program Chronic Care Management Program

Adrienne Shambray ashambray@stu.jsu.edu

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DNP Manuscript Defense Approval

First Name: Last Name: Student ID:

Date:

Choose your DNP program:

Manuscript Title:

Date of Manuscript Approval:

Student Signature Electronically signed by Adrienne Shambray on 06/28/2021 9:34:41 PM

Chair, DNP Manuscript Signature

Electronically signed by Laura Barrow on 06/29/2021 9:49:04 AM

DNP Clinical Coordinator Signature

Electronically signed by Lori McGrath on 06/29/2021 10:01:48 AM

DNP Program Coordinator Signature

Electronically signed by Donna Dunn on 06/29/2021 10:38:22 AM

Director of Online & Graduate Nursing Programs Signature

Electronically signed by Kimberly Helms on 07/01/2021 11:11:39 AM

Dean of Graduate Studies Signature

Electronically signed by Channing Ford on 07/22/2021 4:50:19 PM

Adrienne* Shambray* *

06/28/2021*

nmlkj Adult-Gerontology Acute Care Nurse Practitioner (Doctor of Nursing Practice) nmlkj Family Nurse Practitioner (Doctor of Nursing Practice) nmlkji Post-Master's DNP (Doctor of Nursing Practice)

*

Decreasing the Impact of Diabetes in the Adult and Elderly Rural Health Population Utilizing Phone Calls as Part of the Chronic Care Management Program *

06/29/2021*

ii

DECREASING THE IMPACT OF DIABETES IN THE ADULT AND OLDER

ADULTS RURAL HEALTH POPULATION UTILIZING PHONE CALLS AS PART

OF THE CHRONIC CARE MANAGEMENT PROGRAM

A DNP Project Submitted to the Graduate Faculty

of Jacksonville State University in partial Fulfillment of the

Requirements for the Degree of Doctor of Nursing Practice

By

ADRIENNE SLAUGHTER SHAMBRAY

Jacksonville, Alabama

June 28, 2021

iii

Copyright 2021

All Rights Reserved

_______________________________________________

Adrienne Slaughter Shambray June 28, 2021

iv

ABSTRACT

This quantitative study was developed in order to evaluate the impact of phone calls on

patient outcomes using the Chronic Care Management program (CCM). In January 2015,

the Centers for Medicare and Medicaid Services (CMS) implemented the (CCM), with

the goal of improving health and quality of care for high-risk patients. The administration

and physicians at the clinic of focus for this project recognized a need for the facility to

help improve and manage these patients’ care to prevent issues such as hospital

readmission. This project aimed at following patients in the program with the chronic

condition of diabetes mellitus and tracked previous glycated hemoglobin (A1C) prior to

program and compared the result to the A1C three months into the program. After

participation in the program for a minimum of three months, a quantitative analysis was

completed from the data collected. Results showed the probability of an individual’s A1C

to decrease was 61.8%, which is clinically significant. Nursing has a strong foundation

based in promoting quality of life for patients. This project reflects that goal and has

potential to advance nursing’s mission to promote quality of life moving into the future.

Keywords: Chronic care management, Chronic care protocols, Chronic care, diabetes,

Type 2 diabetes, diabetes management, telehealth

v

ACKNOWLEDGEMENTS

Throughout this process of completing this DNP Manuscript I have received a

great deal of support and assistance. Firstly, I would like to thank my DNP Chair, Dr.

Laura Barrow, and Dr. Crystal Fuller, whose expertise and insight pushed me to sharpen

my thinking and brought my work to a higher level. I would also like to thank Dr. Keith

for her encouragement and assistance to push our class to greater expectations. Secondly,

I would like to thank my colleagues from my internship and preceptor, Dr. Ilinca

Prisacaru for the wonderful collaboration and assistance with my project. Additionally, I

like to thank God, my family, especially my husband for his support and wise counsel.

You are always there for me and assist me with anything I may need. I would like to

thank my parents for their continued support. And finally, my children, Sebastian and

Nicholas, for giving me the drive I needed to complete this project.

vi

TABLE OF CONTENTS

Abstract…………………………………………………………………………………... iv

Introduction………………………………………………………………………………. 1

Background……………………………………………………………………………. 1

Problem Statement..……………………………………………………………………3

Organizational Description of Project Site…………………………………………… 4

Review of Literature………………………………………………………………........... 4

Evidence-Based Practice: Verification of Chosen Option………....…………………..8

Theoretical Framework………………………………........................................................9

Goals, Objectives, & Expected Outcomes…………………………………………... 11

Project Design…………………………………………………………………………… 12

Project Site and Population………………………………………………………….. 13

Setting Facilitators and Barriers……………………………………………………... 14

Implementation Plan/Procedures………………………………………………………... 15

Measurement Instruments…………………………………………………………….15

Data Collection Procedure……………………………………………………………15

Data Analysis…………………………………………………………………………16

Results………………………………………………………………………………...19

Interpretation/discussion…………………………………………………………………20

Cost-Benefit Analysis/Budget…………………………………………………………...22

Timeline………………………………………………………………………………….22

Ethical Considerations/Protection of Human Subjects ………………………………….23

Conclusion……………………………………………………………………………….23

References……………………………………………………………………………….25

ii

Appendices………..……………………………………………………………………...29

Appendix A…………………………………………………………………………....... 29

Appendix B………………………………………………………………………………30

Appendix C………………………………………………………………………………31

Appendix D……………………………………………………………………………... 34

1

Decreasing the Impact of Diabetes in the Adult and Older Adults Rural Health Population

Utilizing Phone Calls as Part of the Chronic Care Management Program

Introduction

The older adult population is continuing to grow and will soon triple in the next

few decades to come. Based on current trends, the population of people greater than 79

years of age will expand from approximately 126.5 million to approximately 446.6

million by 2050. When aging, the population tends to accumulate multiple deficits in

their life that makes them more vulnerable and require more assistance in healthcare. It is

predicted that the growing population will see a decline in daily functions, have

unfavorable health outcomes, and have frequent hospital admissions (Aranha,

Smitherman, Patel, & Patel, 2020). Hospital admissions are costly and can cost insurance

companies and patients millions to billions of dollars yearly. With proper quality of care,

hospital admissions and readmissions can be reduced and occasionally prevented (Chen

& Grabowski, 2019).

Background

Healthcare providers have a responsibility of providing quality care to patients

and preventing hospital admissions and readmissions. Hospitalizations are a burden on

healthcare systems and individuals financially and physically. This may cause

depression, poor social support, and/or polypharmacy for patients; therefore, linking to

patients getting readmitted to the hospital. Another factor of hospital readmission is poor

discharge planning processes where hospital staff may fail to have adequate

2

communication with primary care physicians or patients fail to utilize follow-up visits

(Shih, Buurman, Tynan-McKiernan, Tinetti, & Jenq, 2015). Adequate follow-up with

patients who have been hospitalized is lacking in primary care.

This lack of follow-up care can be costly. Readmissions among Medicare

beneficiaries account for 56% of three0-day readmissions in the United States and cost

$26 billion (Jung, DuGoff, Smith, Palta, Gilmore-Bykovskyi, & Mullahy, 2020).

Approximately, one-quarter of patients develop an adverse effect and half of those events

are preventable. It was estimated about 19.6% of Medicare fee-for-service patients are

re-hospitalized within 30 days of discharge. This accumulates extreme costs; for

example, 3.3 million adults were readmitted to the hospital within three0 days and

resulted in a cost of $41.3 billion. Each year, avoidable hospital readmissions cost

approximately $12 billion (Hudali, Robinson, & Bhattarai, 2017). These statistics prove

the need for interventions to reduce hospital admissions and subsequent costs.

According to Scott (2018), one intervention to reduce these statistics is the

implementation of the Chronic Care Management (CCM) program. CCM services are

provided by a physician or non-physician practitioner such as a nurse practitioner or

physician assistant. The service is provided per calendar month for patients with multiple

chronic conditions. The conditions must meet the expected criteria lasting at least a year,

placing the patient at risk of death, acute exacerbation, or functional decline. The chronic

condition may include Alzheimer’s disease, arthritis, asthma, cancer, chronic obstructive

pulmonary disease, diabetes, heart failure, hypertension, heart disease, or depression

(Scott, 2018). This study will focus on patients with diabetes in the CCM program.

3

Diabetes mellitus is associated with a two to three-fold increase in the likelihood

of contracting cardiovascular diseases. Managing diabetes appropriately and lowering

the glycated hemoglobin (HbA1C) by at least 1% reduces microvascular complications

(Gorina, Limonero, & Alvarez, 2018). The use of an interdisciplinary care team for

diabetes care when combined with self-management diabetic education and glucose-

lowering therapies helps prevent comprehensive lifelong complications. The CCM

program allows a team effort between staff and patients to develop goals for the patient’s

health and manage individual goals that have been set (Del Valle & McDonnell, 2018).

With proper education, patients feel better by increasing their knowledge and experience

and they are protected from possible side effects by controlling the disease. Telephone

reminders are effective in creating behavior change in patients with diabetes in

performing self-management activities (Eroglu & Sabuncu, 2021).

Problem Statement

The adult and older adult population with multiple chronic conditions need

adequate quality of care and follow-up to ensure proper compliance and treatment. The

patient, intervention, comparison, and outcome (PICO) question for this DNP project is

as follows: among the insured adult to older adult patients ages 25 and older, how

effective are monthly telephone calls as part of the CCM program in ensuring adequate

A1C control, compared to patients’ A1C prior to entering the program? The author will

address the PICO question by utilizing monthly phone calls to evaluate a newly

implemented program within a primary care clinic.

4

Organizational Description of Project Site

The population with diabetes continues to rise and is partially due to the lack of

education, patient self-management, and/or patient understanding of the disease. The

help of education and continued follow-up causes an increase in patient’s managing their

care and achieving the goals created for his/her treatment. The project site needed a

protocol to assure providers and staff had the ability to assure proper diabetic education

and counseling as well as giving the patient more access to express one’s needs,

concerns, questions, and understanding (Eroglu & Sabuncu, 2021). According to Eroglu

& Sabuncu (2021), studies show there is a direct link between education and metabolic

control.

Review of Literature

According to Westphal (2019), healthcare and medicine have made great

advances over the decades and have resulted in longevity in human life. This results in

humans living longer with chronic conditions such as heart disease, chronic obstructive

pulmonary disease (COPD), Alzheimer’s disease, stroke, cancer, and diabetes. These

conditions account for two-thirds of deaths and $1.5 trillion of healthcare spending

(Westphal, 2019). According to Cohen et al. (2020), the United States and other

developed nations enjoyed large gains in life expectancy at birth, however, the United

States began to lag behind other nations starting in the 1960s. This poor performance has

been studied and documented to find the proper solution to enhance care. Studies have

shown that patients with insurance versus patients without insurance have improved

5

survival and achieved better outcomes due to access to earlier diagnoses and treatment,

especially individuals with diabetes (Cohen et al., 2020).

According to the Centers for Disease Control and Prevention (CDC) (2021),

diabetes is the seventh leading cause of death in the United States. Approximately

three4.2 million adults in the US have diabetes, and 20% of those people are unaware

they have the diagnosis. In the last twenty years, adults diagnosed with diabetes have

more than doubled (CDC, 2021). Rodriguez et al., (2021) stated providers should follow

recommendations by the American Diabetes Association (ADA) and screen individuals

aged 45-70 years of age who are overweight/obese, individuals with a family history of

diabetes, and individuals with a history of gestational diabetes or polycystic ovarian

syndrome. According to the ADA (2021), if individuals present to the clinical setting

complaining of polyuria, polydipsia, polyphagia, fatigue, blurry vision, slow healing

wounds, weight loss, or paresthesia; the provider should screen the individual for

diabetes. Early detection of diabetes can decrease the risk of developing diabetic

complications (ADA, 2021).

Hospital readmissions have been on the rise for decades due to chronic diseases,

which are one of the most significant challenges the United States healthcare system

confronts. The majority of Medicare beneficiaries have two or more chronic health

conditions. These beneficiaries have more hospitalizations, physician visits, and

emergency room visits when compared to patients with one or no chronic conditions.

Primary care practices provide the majority of the beneficiaries’ care; although, these

practices often receive inadequate funding and infrastructure support. In January 2015,

the Centers for Medicare and Medicaid Services (CMS) implemented a new policy to pay

6

providers or chronic care management services. The goal was to improve health and

quality of care for high-need patients. This program allowed eligible providers to bill

CMS for up to 20 min of non-face-to-face care services in a three0-day period (Wilson,

O’Malley, Bozzolo, McCall, & Ma, 2019).

As stated above, one study estimated that approximately 19.6% of Medicare

patients are hospitalized within thirty days of hospital discharge (Hudali, Robinson, &

Bhattari, 2017). Rehospitalizations also caused an increase in costs in the hospital

setting. In 2011, approximately 3.3 million adults were readmitted to the hospital which

cost about $41.3 billion (Hudali, Robinson, & Bhattari, 2017). By 2016, the three0-day

readmission rate had increased to over 4 million (Bailey, Weiss, Barrett, & Jiang, 2019).

The goal of researchers, hospitals, and policymakers is to reduce preventable patient

readmissions. Billions of dollars are wasted each year due to avoidable hospital

readmission costs. When attempting to reduce readmission rates, the readmission of

high-risk patients was significantly reduced with adequate one-week follow-up

appointments after discharge. Patients who do not receive timely follow-up appointments

with their primary care provider have readmission rates ten times higher than those who

do. This article presented a study that followed a transition of care clinic after discharge.

The study focused on the care for patients in a 30-day window and with the policy and

procedure of follow-up care, the clinic succeeded in reducing the rehospitalization rate

from 11.7% to 3.8%. One method used to help reduce rehospitalization was through

enhancing communication with patients after discharge. This includes post-discharge

phone calls along with community-based education and information through easily

7

accessible electronic health records among inpatient and outpatient providers (Hudali,

Robinson, & Bhattari, 2017)

Xing, Goehring, & Mancuso (2015) study demonstrated that having well-

designed care coordination after discharge can reduce healthcare costs and manage

chronic conditions. Care coordination improves communication among patients and

healthcare providers. This study also showed high-risk patients who benefitted from care

coordination by having a Chronic Care Management program. In this program, a nurse

care manager coordinated the long-term care services, educated patients to better

understand signs of worsening health, and supported patients’ efforts to achieve self-

management goals (Xing, Goehring, & Mancuso, 2015). The program included an initial

comprehensive assessment, an individualized health action plan, and meetings with the

nurse care manager occurring at least once a month. Health action plans were reviewed

and updated every six weeks (Xing, Goehring, & Mancuso, 2015).

Implementing this program can be difficult for clinical practices due to a lack of

infrastructure. The Chronic Care Management (CCM) program was developed by The

Centers for Medicare and Medicaid Services (CMS). It was developed to provide care

coordination activities outside of office visits. A 2015 article by Hodach, addressed the

challenges of the CCM program. One challenge is finding ways to promote greater

patient engagement with the comprehensive care plans required by CMS. Without the

care plan in place, there is a risk for a negative impact on the success of the patient’s

condition. Another challenge was reconfiguring and adapting electronic health records to

be more aligned with CCM. The support of Healthcare Information Technology (IT) can

help ease these challenges (Hodach, 2015).

8

After literature review, the evidence reveals the continued rise of hospitalizations

due to worsening of an individual’s chronic conditions (Aranha, Smitherman, Patel, &

Patel, 2020; Bailey, Weiss, Barrett, & Jiang, 2019). This has caused a strain for patients

physically, emotionally, and financially. Insurance companies have more responsibilities

to manage financially as well. One study found that patients were not receiving the

education needed at hospital discharge which resulted in a decrease in patients’ abilities

to manage their care properly and therefore, returned to the hospital within the 30-day

window (Bailey, Weiss, Barrett, & Jiang, 2019). Another study found that a nurse who

took time to educate a patient and his/her family, establish a care plan, and meet with the

patient often significantly decreased the likelihood the of rehospitalization. Barriers to

this type of program exist, such as patient and staff participation. Therefore, proactive

measures may be needed to mediate these barriers (Chen & Grabowski, 2019).

The CCM program was implemented to help decrease hospitalizations, however,

research shows a lack of information regarding specific chronic conditions such as

diabetes. Because the system is newly introduced, there is a lack of evidence regarding

its impact on diabetic complications and management. More evidence is also needed

regarding the impact of providers counseling patients regularly and the impact on

meeting diabetic goals.

Evidence-Based Practice: Verification of Chosen Option

After a thorough literature review, the program intervention chosen for

implementation focused on patients with diabetes to improve their A1C by adjusting the

CCM program that was established at the rural primary clinic chosen for this study. This

9

intervention focused solely on patients with diabetes with a goal to reduce diabetic

complications; therefore, reducing diabetic-related hospitalizations. The intervention

included close follow-up with these patients through phone calls regarding their self-

management. The phone calls included the needed education and counseling to impact

the desired goals.

Theoretical Framework

This DNP project is based on two theories. One is the interpersonal relations in

nursing theory by Hildegard Peplau which focuses on observations. The second theory is

Neuman’s systems model by Betty Neuman which focuses on examining patients as a

system.

Hildegard Peplau developed the theory of interpersonal relations in nursing, in

which she discussed her belief nursing concepts should come from observations in

nursing. Peplau developed a system combining inductive and deductive reasoning. This

was based on observation (inductive) and known concepts (deductive). She used methods

to examine phenomena of interest and to test an intervention targeted at the problem

(Peplau, 1991). Peplau’s interpersonal model examines the process between the nurse

and patient that works toward a mutual goal. The DNP project will follow this process

when developing goals with the patient at the beginning of the program to help prevent

hospitalization or rehospitalization. The first phase of Peplau’s theory is orientation, in

which the nurse gathers healthcare and other information about the client, and an auto

10

diagnosis is developed regarding the illness/disorder. A nurse may function as a resource

person by giving specific information that aids the patient to understand the situation

(Peplau, 1991). In this concept, introductions are made, questions are asked, and issues

are clarified. Trust and rapport are developed between provider and patient. This phase

also includes contracting, establishing a plan of care, and time limits for visits are

clarified and agreed upon (Peplau, 1991). Initially in the program, the provider discusses

the program and the chronic conditions with the patient. Then, the patient gives consent

to join the CCM program and establish a plan of care. The second core concept of this

model is identification. In this step, the nurse and patient clarify expectations and

determine how to work together. In this phase, the patient’s first impression is clarified;

one feels that he/she knows what the situation can offer; and then responds to persons

who seem to offer the help one needs (Peplau, 1991). The third phase is exploitation, in

which the patient uses the services offered by the nurse and attempts to accept full value

from the relationship that has been established (Peplau, 1991). The final core concept is

resolution. In this step, the patient’s needs have been met and the patient moves toward

independence due to the gradual freeing from being a person that needs help to having

the strength and ability to stand more or less alone (Peplau, 1991). The patient may

reduce interaction times, issues are summarized, and the patient has a health maintenance

plan (Peplau, 1991).

Betty Neuman’s system model states an individual or group is a client system.

Each system is unique but composed of common characteristics. It further states that

nursing interventions can affect the client’s move toward health on several levels. The

11

goal is to promote the system’s stability by assessing the impact of stressors and helping

the client adjust to the environment. Neuman’s systems model focuses on three types of

prevention: primary, secondary, and tertiary prevention, which promote wellness

(Neuman, 1982).

The DNP project used primary prevention by promoting health and wellness to

reduce risk factors and prevent possible medical events. Secondary prevention was

practiced in the CCM program by helping patients amid chronic conditions when a

stressor has occurred. Then tertiary prevention maintained wellness after an event by

continuing to monitor patients monthly (Neuman, 1982). In this project, each patient was

seen and treated as individuals and not as a generic group of individuals with diabetes,

although that was the common characteristic of the project population. Each patient had

time to discuss interventions to improve or stabilize their health and work towards a goal.

Stressors were also discussed, and the relationship was built between the patient and the

provider to assess the stressor and help the patient adjust to his/her environment

(Neuman, 1982).

Goals, Objectives, and Expected Outcomes

The purpose of this project was to establish monthly phone calls to follow patients

in the program with the chronic condition of diabetes and tracked previous A1C prior to

entry compared to A1C three months into the program. Phone calls included a review of

daily glucose readings as well as medication reconciliation. This information is

verbalized to the provider by the patient or caregiver. This allowed the provider to assess

patient/caregiver competency with both glucose monitoring and medication compliance.

12

The provider adjusted medications as needed and provided patient medication education,

also as needed. Data analysis compared A1C prior to entry to A1C three months after

phone calls were initiated and measured any differences for statistical significance. In

addition, any medication administration errors (e.g. patient reports taking incorrect

medication or dosage) from first phone call to last phone call were noted and month one

was compared to month three to analyze for statistically significant changes. The

expected outcome was to show a decrease in A1C in patients that have an A1C greater

than 7% or to stabilize patients who have an A1C less than or equal to 7%.

Project Design

This project was a quantitative, quasi-experimental design and purposive

sampling was used in data collection. It focused on implementing a program to help

reduce hospitalizations and rehospitalizations in Medicare patients with chronic

conditions. Every month a provider contacted the patient for close follow-up on diabetes.

If the patient had complications or questions regarding intervention, medication, or diet;

the phone calls were more frequent such as weekly or bi-monthly. A detailed protocol

was implemented to create a system for consistent care in a rural clinic. The protocol for

the project was developed to help staff continue the program for longevity. Post-surveys

were completed by patients via telephone on the usefulness of the program. Quantitative

data were collected on the percentage of A1Cs and hospitalizations or lack thereof during

the program.

13

Project Site and Population

The project took place at a family practice clinic in an urban area. This

community has a small-town feel but is continuing to develop and grow each year. The

population is approximately 14,000 as of 2019. Of those residents, 86% are Caucasian

and 14% identify as minorities. Approximately 14% lived in poverty (U.S. Census

Bureau, 2019). Only two medical clinics reside in this area. The participants of this

project included patients with Medicare as their primary insurance and had at least two

chronic conditions. They participated by answering the calls every month and

communicating with the staff regularly. The provider was responsible for calling the

patients for follow-up care. Patients were able to contact our staff if they had any

medical questions or problems and the staff were aware of the protocol to help assist with

clerical needs or to notify the provider of the patient’s concern regarding treatment or

his/her condition. Clinical staff for the program included a nurse practitioner who was

the main source of communication with the patients. Medical assistants helped manage

any incoming calls and direct messages to the nurse practitioner for any patient calls that

needed immediate attention and/or had questions outside of the monthly calls.

Recruitment for the program included discussing the project with a patient with diabetes

during his/her lab visit and obtaining the written consent if the patient wanted to join.

When patients decided to join, the next contact via telephone included developing a care

plan with the patient.

14

The practice offers services ranging from newborns to older adults. Service

ranges from wellness visits to acute care visits. Procedures performed at the clinic may

include suturing, ear irrigation, cryotherapy, joint injections, trigger point injections,

incision and drainage, and casting. Each physician has three to four medical assistants,

and each nurse practitioner has one to two medical assistants. Communication between

the author and staff included messages through the charting system and direct

communication.

Setting Facilitators and Barriers

The resources included a guideline from Medicare used when the program was

implemented. Office resources included a provider, medical assistants, lab technicians,

phones, computers, a charting system, and paper. Constraints included time management

of regular clinic visits and managing the program each month. Barriers included patients

not answering phone calls or not wanting to participate with the program after a few

months of being enrolled in the program. Some patients did not want to spend time on

the phone discussing their daily or weekly blood glucose logs. Other patients were not

checking their blood glucose level appropriately or found a pattern of knowing when they

would receive a phone call and check their blood sugar at that time. Another barrier

included lack of proper documentation of staff members if they discussed anything with

the patients regarding diabetes. Having bi-monthly meetings with staff helped reiterate

the need for proper documentation and prevented any burnout or staff becoming lax to

ensure close follow-up, program accuracy and continued care.

15

Implementation Plan/Procedures

Measurement Instruments

The CCM program was established prior to the implementation of the DNP

project but was used as the basis for the patient selection for the project. When

measuring the outcomes of this DNP Project the following instruments were used: the

patient list, the patient information form was used during each phone call to document

data collection and log glucose levels, and the data spreadsheet for results. Approaching

the end of the three months, a phone survey was given to evaluate the project. A

spreadsheet was created for the A1C data entry.

Data Collection Procedures

Pre-intervention consisted of getting the approval for the project from the

Institutional Review Board (IRB) (see Appendix A). The agency was selected for the

project and permission was given to allow the investigator to perform the study for the

project (See Appendix B). Pre-intervention also consisted of developing the protocol for

the continuation of the chronic care program. A list was provided of all Medicare

patients in the office from each physician in the clinic and the investigator sorted the

patients with diabetes from those patients not diagnosed with diabetes. The patients on

16

the list were contacted and made aware of the project and provided with needed

information for enrolling in the program. They gave verbal consent to enroll in the

program and then signed a consent form in the clinic prior to participation (see Appendix

C). For the first data collection, the intervention included obtaining the initial A1C of the

patient from the initiating month or within three months of the start of the project. Then,

each patient was contacted via phone call or in the office to develop a care plan and

develop appropriate goals. For three months, the project investigator called the patient

every month and occasionally called patients weekly due to medication changes and to

discuss any questions the patient had regarding diabetes. A patient information

(Appendix D) form was kept for tracking purposes to monitor patient progress from visit

to visit. Post-intervention included collecting the second A1C for each patient, evaluating

the effectiveness of the program such as evaluating the patient’s second A1C and blood

sugar logs.

Data Analysis

Twenty participants were selected for the study. The participants were between

the ages of 26-8three. The objectives and design have been described in detail elsewhere.

Briefly, the study recruited adults with a diagnosis of diabetes from a rural primary clinic

in the US. Recruitment began in January of 2021 and participants were followed until

April 2021. For data analysis, the participants were divided into four groups by age for

comparison. Group 1 consisted of individuals less than 45 years of age, group 2 included

ages 46-55 years old, group three included ages 56-65 years, and group 4 included

17

participants greater than 65 years of age. The pre- and post-A1C was gathered in the lab

of the rural clinic by certified lab technicians.

A classical analysis was done on the overall A1C results for paired pre and post-

values (see Figure A). This project team selected a one-sample dependent t-test that

showed the true mean is not equal to zero and likely is negative. This analysis reveals

there is no statistically significant difference in overall HbA1C values by the paired pre

and post values (t= -0.55267, df = 19, p-value = 0.5869, CI 95%). According to this

analysis, the mean for pre-intervention A1C was less than 7 and the post-intervention

mean was averaging 7 (J. Cleveland, personal communication, April 21, 2021).

Figure A

18

A Bayesian Analysis (see Figure B) was run to provide further information about

the data. It shows the overall HbA1C to compare the pre- and post-HbA1C mean. It

shows there is no statistically significant difference in overall A1C values by paired pre

and post results. Since the credible interval includes zero, it could be possible that there

was no difference between pre- and post-status results for A1C. However, based on the

data, the probability that an individual’s HbA1C would decrease is 61.8% (J. Cleveland,

personal communication, April 21, 2021).

Figure B

A Bayesian analysis was also used to reveal the results of each age group

mentioned previously (see Figure C). It does present that there is no statistically

19

significant difference in overall HbA1C values (by paired pre and post and by age range

category). Since the confidence interval includes zero, it could be possible that there was

no difference between pre and post and age-range status results for HbA1C (J. Cleveland,

personal communication, April 21, 2021).

Figure C

Results

Although each analysis shows no statistically significant difference, the study has

practical differences. The breakdown of the groups shows there was a decrease in

HbA1C in the group ages 56-65 over a three-month period. The age group of 46-55

remained about the same with an average mean of pre-HbA1C 7.20 and decreased to

20

HbA1C 7.17 during the three-month period. The other two groups showed a slight

increase in the HbA1C over the three-month period. Due to short duration of the study,

any decrease in HbA1C was significant. If the study is continued over the duration of a

year, the overall probability of potential decrease (61.8%) may increase and show

statistical significance (J. Cleveland, personal communication, April 21, 2021).

Interpretation/Discussion

Most society guidelines incorporate recommendations for hemoglobin A1C

monitoring and routine primary care visits in an effort to reduce the burden of diabetes

complications. In a 2018 national database study, patients who regularly received all the

recommended preventative measures, due to close follow-up, experienced a 20% risk

reduction in hospitalization (Albright & Fleischer, 2021). The participants in this study

state in the post-telephone survey that they did not have any hospitalizations during the

duration of this project. The results listed state the overall mean of A1C increased. A

few factors impacted this result. Multiple participant’s A1Cs remained the same. For

example, the pre-A1C was 7.2 and the post-A1C was 7.2. This is still a positive result

because the patient followed the protocol of taking medication regularly, continuing a

diabetic diet, and participating in monthly phone calls. Patients that showed a slight

increase in A1C in Group 1 had trouble accepting every phone call each month due to

work, appointments, or life events. Some of these patients did not always have weekly

glucose logs to present but would state they checked their glucose regularly. Group 4

included patients that had trouble recalling their diabetic medications and some found out

21

they were taking their medication incorrectly. When the patient would have an

appointment at the doctor's office, they would tell the provider that they were taking the

medications on file. For one participant, when asked specifically about each medication

on the initial phone call, the patient stated one could not afford the medicine prescribed

and was taking an old prescription found in the cabinet. The patient stated fear of

disappointing his/her doctor if the truth was told. Education was provided on the harmful

effects this could cause and the ways we could improve this situation.

One limitation of this study is the diabetic maturity of the participants. One

cannot ascertain that the length of time a participant has been a diabetic affects the

attitude towards the project and manner of one’s behavior. A participant who has been a

diabetic for a decade may be inflexible to change if they present with bad eating habits

and not taking their medication and vice versa a participant who has his/her regimen in

place with good habits may skew the results to look better. Another limitation is the

primary exposures and outcome variables such as blood glucose levels, diet, and

medication are self-reported. Self-reporting can be subject to bias among the

participants. Lastly, the data analysis was set to zero although the A1C will never be

zero. With adjustments, the data could change in the future.

The results help one to see the issues that occur in the primary care setting with

patients that do not improve and the reasons for their actions. It is important to see the

patients' improvements but it is also important to see the patients whose A1C did not

decrease. When reflecting on future recommendations, studies should include a larger

sample size in each age group to obtain more data. The data could include race/ethnicity,

22

financial status, and diabetic maturity (timeline since diagnosed with diabetes). Another

recommendation for further studies is a longer duration; the study should continue for at

least one year for more accurate data collection since three months is the recommended

amount of time to obtain an HbA1C. Future studies should consider including a

continuous glucose monitor to obtain more accurate readings from patients.

Cost-Benefit Analysis/Budget

No financial cost was obtained by the office for the project, but time was utilized

from providers and medical staff. If patients are in the CCM program, they were already

aware that their insurance is billed and there was a possibility of obtaining a bill that the

patient will bear if extra services were provided. Patients did not report any additional

fees incurred. This study did not charge any extra finances for the participants. Obtaining

cost or the lack thereof does not affect or benefit this project to monitor their diabetes.

Timeline

The project was originally developed beginning in the summer of 2020 and

implementation began the fall of 2020. Data collection lasted from January 2021 to April

2021, and the analysis was completed in April 2021. When considering the timeline from

start to finish, the project lasted 10 months.

23

Ethical Considerations/Protection of Human Subjects

The Jacksonville State University Institutional Review Board (IRB) approval

(Appendix A) was obtained before initiating the DNP project. All participants were

protected by the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

All patients were coded to protect privacy and all identifiable criteria were removed from

any public reports. The author and personnel followed the standards of care for practice

in the clinical setting. All electronic files containing identifiable information were

password-protected to prevent access by unauthorized users. The project coordinator had

a personal login to electronic health records and all patient information were kept in the

office separate from anything submitted to JSU or taken to another location. No further

risks were introduced to patients other than the usual risks from receiving standard care.

Conclusion

Chronic conditions in the primary care setting must have close follow-up by

healthcare providers. Continuing to follow-up with patients can help decrease further

complications with these conditions, reduce hospitalizations, and ensure continuity of

care. This study showed that close follow-up with individuals with diabetes has the

potential to help decrease hemoglobin A1C in the adult population; therefore, decreasing

both current and future complications, and increasing the cooperation of patients with

their care. Nursing has a strong foundation based on promoting quality of life for

patients. This project reflects that goal and has potential to advance it within the

24

profession moving into the future. In addition, programs such as this can be used for

other chronic diseases. They will be essential moving into a time when chronic diseases

are on the rise and will likely continue to be due to a larger aging population.

25

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29

APPENDIX A

October 30, 2020

Dear Adrienne Shambray:

Your proposal submitted for review by the Human Participants Review Protocol for the project titled: “Decreasing the Impact of Diabetes in the Adult and Elderly Rural Health Population Utilizing Phone Calls as Part of the Chronic Care Management Program” has been approved as exempt. If the project is still in process one year from now, you are asked to provide the IRB with a renewal application and a report on the progress of the research project.

Sincerely

Walsh ecutive Secretary, IRB

30

APPENDIX B

October 20, 2020 To whom it may concern:

Adrienne Shambray, Doctor of Nursing Practice (DNP), student at Jacksonville State University has permission to conduct a Quality Improvement DNP Project, titled — Decreasing the Impact of Diabetes in The Adult and Elderly' Rural Health Population Utilizing the Chronic Care Management Program. This DNP Project may be conducted at this facility.

Sincerely,

«?

Practice Administrator

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APPENDIX C

CONSENT FOR PARTICIPATION IN A STUDY

Title of Project: Decreasing the Impact of Diabetes in the Older adults Rural Health

Population Utilizing Phone Calls as Part of the Chronic Care Management

Program

Investigator Names: Adrienne Shambray & Laura E. Barrow

E-Mail Contact Information: ashambray@stu.jsu.edu , lbarrow@jsu.edu

You are being asked to participate in a research study. Before you give your

consent to volunteer, it is important that you read the following information

and ask as many questions as necessary to be sure you understand what you

are being asked to do.

Investigators

Adrienne Shambray, MSN, CRNP, FNP-C

Laura E. Barrow, PhD, RN

Purpose of the Research

This project identifies patients who quality for the Chronic Care Management Program

(CCM) using criteria from of the Centers for Medicare and Medicaid Services and

who are currently diagnosed with Diabetes Mellitus. The project will utilize

monthly phone calls in order to better assist patients in managing their Diabetes.

Identifying any complications of this disease early may help reduce complications

and improve your overall quality of life.

32

Procedures

If you volunteer to participate in this study, you will be asked to agree to monthly phone

calls lasting approximately 20 to three0 minutes. These calls will focus on your

current illnesses, and specific questions about your Diabetes will be asked. You

will be asked to provide information about your daily blood glucose levels and

your daily medication.

Potential Risks or Discomforts

There are no foreseeable risks, however, you may experience positive or negative

feelings as you respond to questions. The phone calls will be scheduled during

business hours and at your convenience. There are no costs associated with your

participation in the study. You have the right to discontinue participation,

temporarily or permanently, without any consequence.

Potential Benefits of the Research

There are personal benefits for participating in the study. Your participation may identify

complications of your diabetes and lead to earlier treatment. The nursing

profession and clinical practice standards may increase due to the knowledge

obtained in this study.

Confidentiality and Data Storage

Identifying information will be confidential and not be shared with anyone outside the

study.

Data, specific to the study, will be stored in the researchers’ offices on a password-

protected computer. Following the completion of the project, the forms will be

destroyed six months after the study.

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Questions, Participation, and Withdrawal

Your participation in this research study is voluntary. As a participant, you may refuse to

participate at any time. To withdraw from the study, please contact the researchers

at 205-201-three111, 256-490-three625, ashambray@stu.jsu.edu, or

lbarrow@jsu.edu.

Reasons for Exclusion from this Study

The exclusion criteria for this study include patients with the inability to speak English,

not qualifying for the CCM program, or with no diagnosis of diabetes mellitus 2.

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APPENDIX D

Participate Information Form

Name:

Age:

Gender:

Self-identified ethnic identification:

A1C prior to entering program and initiating phone calls: ________________________

Self- reported glucose scores:

Any notes needed regarding glucose:

Self-reported medication reconciliation:

No problems identified: ______

Problems identified: ______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

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Any actions taken by provider:

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

If this is month three, follow up A1C result:

______________